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Chapter FOUR: CHALLENGES TO EFFECTIVE SERVICE PROVISION AND WAYS TO ADDRESS THEM

Introduction

86. Historically, the degree to which pharmacists and, in particular, community pharmacists, have been involved in services to substance misusers has, to a large extent, been determined by changes in drugs legislation as well as by changes in the manner in which healthcare in the United Kingdom is provided and funded. The legal and ethical restrictions to which pharmacists are subjected can, on occasion, cause frustration and lack of understanding on the part of clients and other members of the healthcare professions. This chapter examines the main challenges that are posed by legal, professional, educational and other issues and suggests ways in which these issues might be overcome.

Legal and Ethical Challenges

The Sale and Supply of Medicines

87. The Medicines Act (1968) ¹⁷ and the Misuse of Drugs Regulations (2001) ⁷² (and amendments) govern the sale and supply of medicines. The pharmacist has an obligation to abide by the very precise requirements of the Act and the Regulations and incurs an absolute liability for any failure to do so. There can often be tensions between the pharmacist's legal and ethical responsibilities for patient care. It is illegal, for example, for a pharmacist to supply Controlled Drugs ( CDs) such as methadone other than by way of a legally written prescription. Telephoned or verbal alterations or orders are not allowed.

88. It is likely that the Regulations will be tightened as a result of the Shipman Inquiry ⁷³, particularly in relation to CDs and this could serve to exacerbate the problems even further. It is important that other healthcare professionals (and patients) understand and comply with the legal requirements, that Regulations do not become more restrictive and that those that are already in place are amended to reflect clinical need ( e.g. to allow for supplementary prescribing and extended nurse prescribing of CDs).

89. On 21 November 2002, the Minister for Health and Community Care announced new powers to allow pharmacists and nurses in Scotland to prescribe a wide range of drugs, following diagnosis by a doctor and within an individual clinical management plan. The introduction of these prescribing rights is already helping pharmacists to optimise therapy, improve response to clinical need and adherence to treatment.

Patient Confidentiality and the Sharing of Information

90. The Data Protection Act (1998) ⁷⁴ places a legal duty on data controllers to process data fairly and lawfully, to use no more data than is necessary for the task and to retain it for only as long as it is needed. The Human Rights Act (1998) ⁷⁵ guarantees respect for a person's private and family life. Under the terms of this Act, this right to privacy may be overridden, but only when there is a lawful reason to do so. The common law reinforces the need to obtain patient consent before sharing information. Professional guidelines require healthcare workers to ensure that patients are informed about how information about them is used and that consent requirements are met. Decisions should be taken on a case by case basis in the light of the best available information, which may include advice from the local Data Protection Officer or Caldicott or Information Guardian.

91. The RPSGB's Code of Ethics ⁶⁰ requires pharmacists to respect the confidentiality of information acquired about patients and their families in the course of their professional practice. There are occasions when, in the best interests of the patient, information needs to be shared between health professionals and drug users.

This is particularly so in the case of substance misuse where the emphasis is very much on multidisciplinary team working. This calls for a culture of openness and trust between agencies and agreement on the core elements of information that need to be transferred.

92. The findings of the Bichard Inquiry ⁷⁶ will doubtless have an impact on current practice in terms of the effectiveness of record keeping and information sharing with other agencies.

93. In all cases, sharing of information should take place within an environment of informed client consent. Any written or verbal agreement or contract between the patient and the pharmacist should make it clear that these situations may occur and should describe the action that would be taken.

94. Access to records for individuals who are homeless is particularly problematic. In addition, for many individuals, the period immediately following release from prison is a vulnerable time, especially if they have not voluntarily agreed to participate in the Transitional Care Programme available to short-term and remand prisoners in the Scottish Prison Service ( SPS). Most parts of Scotland are far from achieving this level of access at the present time. This situation should improve dramatically with the advent of electronic patient records although agreement urgently needs to be reached for records to be shared between the SPS and NHSScotland.

Patient Access to Health Records

95. Patients, or their legally appointed representatives, have the right to see and obtain a copy of personal health information held about them. Pharmacists should facilitate this right of access. Exceptions to this rule would apply if access to the record could cause serious harm to the patient's or someone else's physical or mental health; could identify someone else; or be subject to legal restrictions.

Duty of Care

96. Pharmacists owe a duty of care to their patients and customers. A duty of care arises when the pharmacist can reasonably foresee that the patient is likely to suffer harm from his/her conduct, e.g. liability for professional services such as dispensing, misleading or deficient advice, etc. The pharmacist also has a duty of care to ensure that prescriptions are not inadvertently supplied to the wrong person. The mandatory introduction of Standard Operating Procedures ( SOPs) by the RPSGB should assist pharmacists to provide the necessary levels of care and act as a safeguard against error. The duty of care obligation also extends to the safety and security of customers and other staff while they are on the premises (occupiers' liability).

The Care of Young People Under 16

97. The Children (Scotland) Act 1995 ⁷⁷, the UN Convention on the Rights of the Child (1989) ⁷⁸, and the Age of Legal Capacity (Scotland) Act 1991 ⁷⁹, are the main pieces of legislation that deal with the care and welfare of children in Scotland. The framework of the Scottish legislation respects the privacy and dignity of young people, their right to make certain decisions for themselves and the right to a say in who should and should not be involved in their care. When deciding on the best way forward, pharmacists should bear in mind the legal rights of the child concerned. However, pharmacists also need to recognise the rights of the parents and to balance this against the right of the child to confidentiality.

98. An increasing number of publications on substance misuse now include references to young people under the age of 16. For example, the Effective Interventions Unit ( EIU) and Lloyds TSB Foundation for Scotland's Partnership Drugs Initiative has collaborated to produce a guide to inform and support the design and delivery of services for children and young people under the age of 16 who have had problems with drugs and/or substance misuse ⁸⁰. More recently, the EIU has produced a guide to inform the design and delivery of effective assessment for young people with problematic substance misuse ⁸⁰. Furthermore, The Scottish Executive has issued revised guidance on needle and syringe exchange schemes in HDL (2002)90 ⁸² which includes a reference to the particular needs of this age group. The Scottish Drugs Forum, in recognition of the fact that a small number of young children might be exposed to very serious risk through intravenous drug use, has produced a leaflet for children under the age of 16 ⁸³.

99. The care of young people should also include the care of babies/young children of drug-using parents. Pregnancy is often an event which prompts women to want to stop using drugs. There is an opportunity here for pharmacists to advise on appropriate nutrition and folic acid intake during pregnancy, as well as try to ensure that the mother-to-be makes contact with relevant services and is in receipt of ante-natal care. After the birth, mother and baby are sometimes separated in hospital and the mother is often discharged home with her baby whilst still withdrawing from her drug. Post-natal support is essential for the maintenance of health and well-being in both mother and child. More places for special care are required in hospital.

100. Some parents/guardians bring their children into the pharmacy when they come to receive their daily dose of methadone. The pharmacist is then faced with the dilemma of either leaving the children unattended in the shop or bringing them through into a separate area where they would be exposed to seeing their parent taking methadone. Taken in context, seeing a parent or guardian receive their daily dose of methadone is probably the least harmful thing that could happen to the child.

Professional Challenges

Service Capacity

101. Around 600,000 people in Scotland visit their pharmacist every day for a range of advice on healthcare and medicines ¹.

102. Prescription volumes have increased from 40.1 million in 1987/88 to 69.5 million items in 2002/03. This represents an average year-on-year growth of 3.7% ⁸⁴. The increase reflects not only the availability of new or more effective medicines, but also increasing patient expectation and, more recently, the implementation of clinical guidelines and recommendations.

103. Prescriptions for methadone have increased sharply over the past 5 years. In 1998/99 there were 214,921 prescriptions or 42 per 1,000 population and in 2002/03 there were 358,389 prescriptions or 71 per 1,000 population. It should be noted, however, that "prescriptions" or the "rate of prescriptions" per area do not allow for comparison between areas due to differences in prescribing practice. These figures are shown by NHS Board in Appendix VII.

104. In 1999/00 there were 2,185,109 instalment and 32,473 single dispensings of methadone mixture. In 2003/04 there were 4,050,783 instalment and 55,311 single dispensings of methadone mixture ⁸⁴. These figures should, however, be treated with caution. In July 2000 there was a major change in the way prescriptions were claimed, as well as in the method of recording information at Information Services Division ( ISD). This means that direct comparison between these two sets of figures is therefore inadvisable because they are derived from different methods of data collection ⁸⁴.

105. There is clearly a limit to the number of services that can be provided by pharmacists working within existing resources. Desire to meet demand should be tempered by the need to uphold patient safety and quality of care. Any additional services should therefore be developed on a selective basis in the first instance.

Team Working

106. It is often difficult for pharmacists to become integrated into the shared care team. Their ability to attend daytime meetings, case conferences, training events, etc., is adversely affected because of the legal requirement to be present in the pharmacy at all times during opening hours in order to supervise the dispensing of prescriptions and the sale of Pharmacy Medicines (P). There is therefore a legal obligation for the owner or manager to ensure that a pharmacist is present during his/her absence. In practice this usually means for the minimum of half a day. In Greater Glasgow, a "peripatetic pharmacist" was appointed on a trial basis to provide, among other things, locum cover to enable individual community pharmacists to attend case conferences, assessment meetings, etc., relating to individual patients and/or GP practice multi-professional/disciplinary training sessions ⁸⁵.

107. Studies should be made of how staff from other professions ( e.g. general medical and dental practitioners) manage to provide cover without the need for a qualified full-time professional presence on the premises. If and when workable alternatives can be found, the law should be challenged in order to free-up valuable pharmacist time. In addition to cover, there is also the question of funding. Without adequate compensation it is often impossible for pharmacists to participate fully in professional activities which take place off the premises.

108. The pharmacist should be seen as being one member of a team of equals. In practice, the pharmacist and the other members of the core team (the General Practitioner, the community psychiatric nurse, the drugs worker, etc) do not appear to operate in tandem. An unwillingness to share information because of a perceived need to maintain patient confidentiality can result in a sense of professional isolation and frustration. Such an approach inevitably impacts upon the treatment plan and the overall quality of patient care.

109. A multi-agency agreement needs to be put in place so that all members of the team and, most importantly, the patient, know what information is being shared and why and the extent of the responsibility for each of the parties involved.

Provision of Pharmaceutical Advice

110. All NHS Boards and all pharmacy contractors should have access to, and receive professional support from, a Specialist Pharmacist in Substance Misuse ( SPiSM). Essentially, the role of the SPiSM is to provide a professional lead for the pharmaceutical aspects of substance misuse services whilst developing and improving the quality of pharmaceutical aspects of patient care in the provision of substance misuse services. These posts already exist in some NHS Boards and other Boards are in the process of making such appointments (see Appendix IX). The remits of the existing posts are not identical. Some are specifically drug-orientated whilst others cover a wider remit ( e.g. alcohol misuse). There are historical and geographical differences to the posts which define the involvement of the individual post holders within primary and secondary care and the wider health and social care environment.

111. Key functions include:

• monitoring and evaluating the supervised consumption of methadone programmes and pharmacy-based needle exchange schemes in terms of cost and quality of service
• providing support and advice to community pharmacists involved in the continuing care of substance misusers
• providing education and training to pharmacists and other health professionals on the pharmaceutical aspects of substance misuse
• undertaking and encouraging clinical audit and practice research in aspects of substance misuse
• liaising with other professionals including social work, police, and
• providing support for the planning and implementation of services through DAATS.

112. Given the increased involvement of pharmacy in this expanding field it is appropriate for DAATS, NHS Boards and their Operating Divisions to consider the employment of Specialist Pharmacists in Substance Misuse, ( SPiSMs). In addition, there is an increasing recognition by drug services that they require access to specialist pharmaceutical advice ⁸⁵.

Educational Challenges

113. At present, not all pharmacists regard substance misuse as being an area in which to gain additional knowledge and expertise. Effort has been expended on other "clinical priority" areas such as coronary heart disease, diabetes and asthma. Steps need to be put in place to redress the balance in order to ensure that more pharmacists are well placed to provide services to substance misusers as part of a multidisiciplinary team.

114. Undergraduate education at the two Scottish Schools of Pharmacy already includes substance misuse as part of the curriculum. However, following graduation, the subject should also become an integral element of pharmaceutical care modules within and beyond the pre-registration year.

115. NHS Education for Scotland (Pharmacy) has produced two training packages available for pharmacists involved in the pharmaceutical care of substance misusers ^86,87. The profession needs to build on this initiative in order to ensure the development of a sustained and integrated approach to education and training. These are currently being updated.

116. The Scottish Training in Drugs and Alcohol ( STRADA) initiative, which is a partnership between the University of Glasgow and DrugScope, has a central role to play in ensuring that the competence of professional staff delivering services to substance misusers is raised throughout Scotland and that interventions to address substance misuse are evidence-based. Working in parallel with STRADA, Healthwork UK, on behalf of all the UK Health Departments, developed a set of competencies for staff working in drug and alcohol services. STRADA and the Royal College of General Practitioners have been commissioned by the Scottish Executive to develop a multidisciplinary drug misuse training programme for Scotland.

117. A wide range of professionals from both within and outwith NHSScotland are involved in contributing to services for substance misusers. Many facets of education and training will have a common thread that will be pertinent to all service providers. It is important that all professionals keep abreast of the latest developments, establish a mutual understanding of each other's roles and adopt a consistent approach to service delivery and patient care. The potential for shared learning and networking is considerable and a multidisciplinary approach should lead to enhanced team working. Much of the success of this approach will be dependent upon pharmacists and other professional staff having the necessary resources to attend daytime meetings in order to participate in these events.

118. Pharmacists have a role to play in the education and training of front-line staff ( e.g. receptionists in GP surgeries and pharmacy support staff in community pharmacies). Community pharmacists also act as a point of contact to enable other professionals and workers, such as Social Work Staff, Local Authority Staff, Drug Workers, etc., to reach patients and clients utilising, for example, a multi-agency agreement.

Other Challenges

Information Technology

119. Significant progress is likely to be made within the next two years in terms of the delivery of new e-systems and e-applications within pharmacy practice. For example, the latest version of GPASS includes the electronic transfer of prescriptions ( ETP) module as standard. Non- GPASS system suppliers have been provided with a description of the ETP system and will now be provided with a detailed specification. The connection of all community pharmacies to the NHSnet is another vital infrastructure development.

120. A connection programme was commenced in October 2003 and will run through to the end of 2005. For community pharmacists connection to the NHSnet, and through it, access to NHSmail, will be pivotal to their ability to deliver on The Right Medicine and the new community pharmacy contract. The benefits of computer-generated scripts, records and registers will be invaluable for service delivery, especially in terms of services to substance misusers which are heavily reliant upon partnership working at a multi-agency level.

Access

121. Current access to pharmacy services out of hours is variable. Some areas rely on individual pharmacies choosing to open, while others have a rota service covering Sundays and public holidays. Problems often occur on Bank Holidays or when ancillary services have closed for the weekend. There is the related issue of pharmacists' inability to contact prescribers when there are problems, particularly at weekends. In some of these instances, it would be helpful if a pharmacist could reactivate a prescription and endorse the fact that a dose had been changed.

122. Extending opening hours would improve the service to those who are receiving treatment for problem drug use, especially for those who have found employment or are attending a course of training. On the positive side, one of the action points in The Right Medicine commits NHS Boards to review their Out of Hours Services to improve public access and the Scottish Specialists in Pharmaceutical Public Health Group have recently published an Out of Hours needs assessment toolkit ⁸⁸.

Social Inclusion

123. Poverty and deprivation are significant and persistent problems in both urban and rural areas of Scotland. As well as geographical pockets of deprivation, some groups face particular forms of disadvantage. These include people from minority ethnic groups, asylum seekers, "travelling people", the homeless and groups vulnerable to poverty. They also include people with chaotic lifestyles.

124. The Scottish Executive's report Drug Misuse and Deprived Communities published in December 2000 ⁸⁹ by the Social Inclusion, Housing and Voluntary Sector Committee, is relevant to this issue.

125. Consideration should be given to the provision of a service that is sensitive to the social as well as the clinical needs of the patient. In the context of pharmaceutical care, this means that services need to be developed as part of the broader spectrum to engage people from disadvantaged backgrounds, especially the homeless and those who might not choose to enter a pharmacy of their own accord.

The Homeless

126. Many substance misusers are homeless or living at the margins of homelessness in insecure or temporary accommodation. In 2001, a review of the Rough Sleepers Initiative ( RSI) in Glasgow ⁹⁰ suggested that about half of rough sleepers between the age of 25-34 years and about one third of rough sleepers between the ages of 16-24 years were dependent on heroin. Similarly, a study of 200 substance misusers in Glasgow and Dundee showed that one third were homeless and two-thirds had experienced homelessness at some stage ⁹¹. The chaos in which these people live means that they fail to stay engaged with services which makes it very difficult to retain them on a course of treatment for any length of time. Cross-agency working (health, social work, police and prisons) needs to be greatly improved if there is to be any semblance of continuity of service provision.

127. Homeless people experience great difficulty in accessing health care. For example, many are not registered with a general practitioner and many general practitioners are unwilling to prescribe for them because of the potential for overdose and problems associated with the safe storage of substitute medication.

128. Apart from providing advice on harm minimisation/safer injecting practices, vein damage, wound management and hepatitis, etc., pharmacists are well placed to act as the "gateway" to other services. This access to care could be improved if there were clear pathways and referral systems to other places such as hostels or voluntary agencies for the homeless. There is also a need to explore new ways of delivering services [ e.g. outreach via non-traditional pharmacy premises such as hostels for the homeless] to encourage greater uptake.

Street Workers

129. Many street workers have drug problems. Again, pharmacists are well-placed to offer advice on safer sex, provide condoms and other OTC contraceptive products and offer emergency hormonal contraception ( EHC). Pharmacists may also offer advice on access to other services for this group of clients. Again, there is a need to consider new ways in which these services can be developed and delivered [ e.g. the use of a mobile service] to encourage greater uptake.

Privacy

130. In recent years there has been a move to provide a private area where questions can be asked and advice given in private. The need for such an area is particularly relevant in the case of substance misuse ( e.g. supervised administration of methadone and the supply of clean injecting equipment), when clients need to have the opportunity to discuss matters privately with the pharmacist away from the open counter.

131. Some existing premises will be capable of adaptation to provide consultation areas and a recent estimate suggests that as many as 50% of pharmacies already have private areas for consultation purposes. For many community pharmacy owners, providing a quiet area could involve a significant redesign, or re-location, of the premises. Scotland has led the way in providing funding for the adaptation of private areas for consultation and the Scottish Executive and NHS Boards should be congratulated on this initiative.

Proof of Identity

132. In 1997 a pharmacist was referred to the Statutory Committee for allegedly supplying a prescription to the wrong patient and failing to take remedial action ⁹².

A reported incident in Glasgow underlines the need for pharmacists to ensure that the person presenting a prescription for methadone (whether supervised or not) is the person to whom the prescription belongs ⁹³. The advent of e-pharmacy will help the pharmacist to check more fully that the person presenting the prescription is not already in receipt of a prescription from another source.

133. Pharmacists should consider establishing a method of patient identification (patient record or photo-card). In general terms, proof of identity is not so much an issue with service users as with staff. Whatever strategy is adopted it must be acceptable from the point of view of civil liberties and is likely to vary from client to client and area to area.

Security

134. The RPSGB's multidisciplinary Working Party Report on Pharmaceutical Services to Drug Misusers ⁹⁴ recognised that the safety and security of the public, pharmacists and their staff is of paramount importance.

135. Theft from pharmacies and attacks on staff are increasing problems. These are not necessarily related to substance misusers per se nor are they confined to pharmacies since they are also being experienced across the whole of the retail sector. Safety issues can be discussed with the local police and community safety. Some Operating Divisions have provided funding for appropriate safety precautions such as CCTV and/or the installation of panic buttons linked to the police in those pharmacies that provide a needle and syringe exchange facility and/or a supervised methadone service.

Public Perceptions

136. There can be local opposition to pharmacy-based services for substance misusers. This is particularly the case in relation to needle exchange schemes because local residents assume that they will bring "drug addicts" into the area. NHS Boards should actively obtain the support of Local Authorities and police services when organising public education campaigns advocating the benefits of these services to the community.

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